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Item 9A. Controls and Procedures

2025-03-27 compared with 2024-03-28 · 349 added, 275 removed, 701 unchanged (47% of the section changed)

7 unchanged sentences

Evaluation of Disclosure Controls and Procedures

Our management, with the participation of our Chief Executive Officer and Chief Financial Officer, has evaluated the effectiveness of the design and operation of our

disclosure controls and procedures, (as such term is defined in Rules 13a-15(e) and 15d-15(e) under the Securities Exchange Act of 1934 (the “Exchange Act”)), as of December 31, 2023.

Based on that evaluation, management has concluded that, as of

such date, our disclosure controls and procedures were effective at the reasonable assurance level.

We maintain disclosure controls and procedures that are designed to ensure that information required to be disclosed by us in reports that we file or submit under the

Exchange Act is recorded, processed, summarized, and reported within the time periods specified in SEC rules and forms, and that such information is accumulated and communicated to our management, including our Chief Executive Officer and Chief

Our management, with the participation of our Chief Executive Officer and Chief Financial Officer, has evaluated the effectiveness of the design and operation of our disclosure

controls and procedures, (as such term is defined in Rules 13a-15(e) and 15d-15(e) under the Securities Exchange Act of 1934 (the “Exchange Act”)), as of December 31, 2024.

Based on that evaluation, management has concluded that, as of such date,

our disclosure controls and procedures were effective at the reasonable assurance level.

We maintain disclosure controls and procedures that are designed to ensure that information required to be disclosed by us in reports that we file or submit under the Exchange

Act is recorded, processed, summarized, and reported within the time periods specified in SEC rules and forms, and that such information is accumulated and communicated to our management, including our Chief Executive Officer and Chief

Financial Officer, as appropriate, to allow timely decisions regarding required disclosure.

In designing and evaluating our disclosure controls and procedures, management recognized that disclosure controls and procedures, no matter how well conceived and operated,

can provide only reasonable, not absolute, assurance that the objectives of the disclosure controls and procedures are met.

Additionally, in designing disclosure controls and procedures, our management necessarily was required to apply its

judgment in evaluating the cost-benefit relationship of possible disclosure controls and procedures.

The design of any disclosure controls and procedures also is based in part upon certain assumptions about the likelihood of future events, and

there can be no assurance that any design will succeed in achieving its stated goals under all potential future conditions.

In designing and evaluating our disclosure controls and procedures, management recognized that disclosure controls and procedures, no matter how well conceived and operated, can

provide only reasonable, not absolute, assurance that the objectives of the disclosure controls and procedures are met.

Additionally, in designing disclosure controls and procedures, management was required to apply its judgment in evaluating the

cost-benefit relationship of possible disclosure controls and procedures.

The design of any disclosure controls and procedures also is based in part upon certain assumptions about the likelihood of future events, and there can be no assurance

that any design will succeed in achieving its stated goals under all potential future conditions.

Management's Report on Internal Control over Financial Reporting

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Changes in Internal Control over Financial Reporting

There has been no change in our internal control over financial reporting in our most recent fiscal quarter that has materially affected, or is reasonably likely to

materially affect, our internal control over financial reporting.

There has been no change in our internal control over financial reporting in our most recent fiscal quarter that has materially affected, or is reasonably likely to materially

affect, our internal control over financial reporting.

Other Information

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Certain information required by Part III is omitted from this Annual Report on Form 10-K because we intend to file a definitive Proxy Statement for the Annual Meeting of

Stockholders pursuant to Regulation 14A of the Securities Exchange Act of 1934 (the Proxy Statement), not later than 120 days after the end of the fiscal year covered by this Annual Report on Form 10-K, and the applicable information included in

the Proxy Statement is incorporated herein by reference.

Stockholders pursuant to Regulation 14A of the Securities Exchange Act of 1934, not later than 120 days after the end of the fiscal year covered by this Annual Report on Form 10-K, and the applicable information included in the Proxy Statement is

incorporated herein by reference.

Directors, Executive Officers and Corporate Governance

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Financial Statements:

The information concerning our consolidated financial statements, and Report of Independent Registered Public Accounting Firm (PCAOB ID 185 ) required by this Item is incorporated by reference herein to the section of this Annual Report on Form 10-K in Item 8, entitled “Financial

Statements and Supplementary Data”.

Financial Statement Schedules:

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information required is shown in the financial statements or the notes thereto.

The list of exhibits required by Item 601 of Regulation S-K is set forth in the Exhibit Index immediately preceding the signature page to this Annual Report on Form 10-K and

is incorporated herein by reference.

The list of exhibits required by Item 601 of Regulation S-K is set forth in the Exhibit Index immediately preceding the signature page to this Annual Report on Form 10-K and is

incorporated herein by reference.

Form 10-K Summary

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Exhibit Description

Placement Agency Agreement, dated February 26, 2025, between PDS Biotechnology Corporation and A,G,P./Alliance Global Partners (filed as Exhibit 10.2 to the Company’s Current Report on Form 8-K filed on

February 28, 2025, and incorporated by reference herein).

Agreement and Plan of Merger and Reorganization, dated November 23, 2018, by and among Edge Therapeutics, Inc., Echos Merger Sub, Inc.

Biotechnology Corporation (filed as Exhibit 2.1 to the Company’s Current Report on Form 8-K filed on November 26, 2018, and incorporated by reference herein).

and PDS Biotechnology Corporation (filed as Exhibit 2.1 to the

Company’s Current Report on Form 8-K filed on November 26, 2018, and incorporated by reference herein).

Amendment No.

1 to Agreement and Plan of Merger and Reorganization, dated January 24, 2019, by and among Edge Therapeutics, Inc., Echos Merger Sub,

and PDS Biotechnology Corporation (filed as Exhibit 2.1 to the Company’s Current Report on Form 8-K filed on January 30, 2019, and incorporated by reference herein).

1 to Agreement and Plan of Merger and Reorganization, dated January 24, 2019, by and among Edge Therapeutics, Inc., Echos Merger Sub, Inc.

and PDS Biotechnology Corporation (filed as Exhibit

2.1 to the Company’s Current Report on Form 8-K filed on January 30, 2019, and incorporated by reference herein).

Eighth Amended and Restated Certificate of Incorporation of Edge Therapeutics, Inc.

(filed as Exhibit 3.1 to the Company’s Current Report on Form 8-K

filed on October 6, 2015, and incorporated by reference herein).

Third Amended and Restated Bylaws of PDS Biotechnology Corporation (filed as Exhibit 3.1 to the Company’s Current Report on Form 8-K filed on March

15, 2022, and incorporated by reference herein).

Certificate of Amendment to Amended and Restated Certificate of Incorporation (filed as Exhibit 3.1 to the Company’s Current Report on Form 8-K on

March 18, 2019, and incorporated by reference herein).

Certificate of Amendment to Amended and Restated Certificate of Incorporation (filed as Exhibit 3.2 to the Company’s Current Report on Form 8-K on

March 18, 2019, and incorporated by reference herein).

(filed as Exhibit 3.1 to the Company’s Current Report on Form 8-K filed on October 6, 2015, and incorporated by reference

Third Amended and Restated Bylaws of PDS Biotechnology Corporation (filed as Exhibit 3.1 to the Company’s Current Report on Form 8-K filed on March 15, 2022, and incorporated by reference herein).

Certificate of Amendment to Amended and Restated Certificate of Incorporation (filed as Exhibit 3.1 to the Company’s Current Report on Form 8-K on March 18, 2019, and incorporated by reference herein).

Certificate of Amendment to Amended and Restated Certificate of Incorporation (filed as Exhibit 3.2 to the Company’s Current Report on Form 8-K on March 18, 2019, and incorporated by reference herein).

Certificate of Amendment to Amended and Restated Certificate of Incorporation (filed as Exhibit 10.1 to the Company’s Current Report on Form 8-K on June 24, 2024, and incorporated by reference herein).

Form of Certificate of Common Stock (filed as Exhibit 4.1 to the Company’s Pre-Effective Amendment No.

1 to the registration statement on Form S-1

333- 206416) filed on September 21, 2015, and incorporated by reference herein).

Description of Securities (filed as Exhibit 4.10 to the Company’s Annual Report on Form 10-K filed on March 27, 2020, and incorporated by reference

Form of Indenture (filed as Exhibit 4.3 to the Company’s registration statement on Form S-3 (File No.

333-267041) on August 24, 2022, and

incorporated by reference herein).

Form of Warrant issued under the Venture Loan and Security Agreement, dated August 24, 2022 (filed as Exhibit 10.1 to the Company’s Quarterly Report

on Form 10-Q on November 14, 2022, and incorporated by reference herein).

Venture Loan and Security Agreement, dated August 24, 2022, by and among Horizon Technology Finance Corporation, as a lender and collateral agent,

Powerscourt Investments XXV, LP, as a lender, PDS Operating Corporation, as a guarantor, and PDS Biotechnology Corporation, as borrower (filed as Exhibit 10.2 to the Company’s Quarterly Report on Form 10-Q on November 14, 2022, and

1 to the registration statement on Form S-1 (File No.

333- 206416) filed on September 21, 2015, and

incorporated by reference herein).

Clinical Trial Collaboration and Supply Agreement, dated May 19, 2017, by and between PDS Biotechnology Corporation and MSD International GmbH (filed

as Exhibit 10.24 to the Company’s Registration Statement on Form S-4/A on January 25, 2019, and incorporated by reference herein).

Patent License Agreement, dated January 5, 2015, by and between PDS Biotechnology Corporation and National Institutes of Health, as amended by First

Amendment, dated August 5, 2015 (filed as Exhibit 10.25 to the Company’s Registration Statement on Form S-4/A on January 25, 2019, and incorporated by reference herein).

Cost Reimbursement Agreement, dated November 1, 2015, by and between PDS Biotechnology Corporation and University of Kentucky Research Foundation

(filed as Exhibit 10.27 to the Company’s Registration Statement on Form S-4/A on January 25, 2019, and incorporated by reference herein).

Public Health Service Cooperative Research & Development Agreement for Intramural-PHS Clinical Research, dated effective as of February 2, 2015,

by and between the National Cancer Institute and PDS Biotechnology Corporation (filed as Exhibit 10.28 to the Company’s Registration Statement on Form S-4/A on January 25, 2019, and incorporated by reference herein).

DOTAP Chloride Enantiomer License Agreement effective November 1, 2008, between Merck Eprova AG and PDS Biotechnology Corporation (filed as Exhibit

Description of Securities (filed as Exhibit 4.10 to the Company’s Annual Report on Form 10-K filed on March 27, 2020, and incorporated by reference herein).

Form of Indenture (filed as Exhibit 4.3 to the Company’s registration statement on Form S-3 (File No.

333-267041) on August 24, 2022, and incorporated by reference herein).

Form of Pre-Funded Warrant (February 2025 Offering) (filed as Exhibit 4.1 to the Company’s Current Report on Form 8-K filed on February 28, 2025, and incorporated by reference herein).

Form of Common Warrant (February 2025 Offering) (filed as Exhibit 4.2 to the Company’s Current Report on Form 8-K filed on February 28, 2025, and incorporated by reference herein).

Form of Warrant issued under the Venture Loan and Security Agreement, dated August 24, 2022 (filed as Exhibit 10.1 to the Company’s Quarterly Report on Form 10-Q on November 14, 2022, and incorporated by

reference herein).

Venture Loan and Security Agreement, dated August 24, 2022, by and among Horizon Technology Finance Corporation, as a lender and collateral agent, Powerscourt Investments XXV, LP, as a lender, PDS Operating

Corporation, as a guarantor, and PDS Biotechnology Corporation, as borrower (filed as Exhibit 10.2 to the Company’s Quarterly Report on Form 10-Q on November 14, 2022, and incorporated by reference herein).

Clinical Trial Collaboration and Supply Agreement, dated May 19, 2017, by and between PDS Biotechnology Corporation and MSD International GmbH (filed as Exhibit 10.24 to the Company’s Registration Statement

on Form S-4/A on January 25, 2019, and incorporated by reference herein).

Patent License Agreement, dated January 5, 2015, by and between PDS Biotechnology Corporation and National Institutes of Health, as amended by First Amendment, dated August 5, 2015 (filed as Exhibit 10.25

to the Company’s Registration Statement on Form S-4/A on January 25, 2019, and incorporated by reference herein).

License Agreement dated as of December 30, 2022 by and between Merck KGaA, Darmstadt, Germany and PDS Biotechnology Corporation (filed as Exhibit

10.9 to the Company’s Annual Report on Form 10-K filed on March 28, 2023, and incorporated by reference herein).

Share Transfer Agreement by and between PDS Biotechnology Corporation and Merck KGaA, Darmstadt, Germany.

(filed as Exhibit 10.1 to the Company’s

Current Report on Form 8-K on January 3, 2023, and incorporated by reference herein).

PDS Biotechnology 2010 Equity Incentive Plan, and forms of agreement thereunder (filed as Exhibit 10.2 to the Company’s Registration Statement on

Form S-1/A on September 21, 2015, and incorporated by reference herein).

Third Amended and Restated PDS Biotechnology Corporation 2014 Equity Incentive Plan (filed as Exhibit 10.1 to the Company’s Current Report on Form

8-K on July 17, 2023, and incorporated by reference herein).

Employee Stock Option Agreement under the Second Amended and Restated PDS Biotechnology Corporation 2014 Equity Incentive Plan (filed as Exhibit 10.4

to the Company’s Current Report on Form 8-K filed on December 9, 2020, and incorporated by reference herein).

PDS Biotechnology Corporation 2009 Stock Option Plan, as amended (filed as Exhibit 99.1 to the Company’s Registration Statement on Form S-8 on June

Cost Reimbursement Agreement, dated November 1, 2015, by and between PDS Biotechnology Corporation and University of Kentucky Research Foundation (filed as Exhibit 10.27 to the Company’s Registration

Statement on Form S-4/A on January 25, 2019, and incorporated by reference herein).

Public Health Service Cooperative Research & Development Agreement for Intramural-PHS Clinical Research, dated effective as of February 2, 2015, by and between the National Cancer Institute and PDS

Biotechnology Corporation (filed as Exhibit 10.28 to the Company’s Registration Statement on Form S-4/A on January 25, 2019, and incorporated by reference herein).

DOTAP Chloride Enantiomer License Agreement effective November 1, 2008, between Merck Eprova AG and PDS Biotechnology Corporation (filed as Exhibit 10.29 to the Company’s Registration Statement on Form

S-4/A on January 25, 2019, and incorporated by reference herein).

License Agreement dated as of December 30, 2022 by and between Merck KGaA, Darmstadt, Germany and PDS Biotechnology Corporation (filed as Exhibit 10.9 to the Company’s Annual Report on Form 10-K on March

28, 2023, and incorporated by reference herein).

PDS Biotechnology Corporation 2018 Stock Option Plan (filed as Exhibit 99.2 to the Company’s Registration Statement on Form S-8 on June 4, 2019, and

Share Transfer Agreement by and between PDS Biotechnology Corporation and Merck KGaA, Darmstadt, Germany.

(filed as Exhibit 10.1 to the Company’s Current Report on Form 8-K on January 3, 2023, and

incorporated by reference herein).

Form of PDS Biotechnology Corporation Option Agreement for 2009 Stock Option Plan, as amended (filed as Exhibit 99.3 to the Company’s Registration

Statement on Form S-8 on June 4, 2019, and incorporated by reference herein).

Form of PDS Biotechnology Corporation Option Agreement for 2018 Stock Incentive Plan (filed as Exhibit 99.4 to the Company’s Registration Statement

on Form S-8 on June 4, 2019, and incorporated by reference herein).

PDS Biotechnology Corporation 2019 Inducement Plan, as amended (filed as Exhibit 10.1 to the Company’s Current Report on Form 8-K filed on January

22, 2024, and incorporated by reference herein).

Form of Stock Option Grant Notice and Stock Option Agreement under the 2019 Inducement Plan (filed as Exhibit 10.2 to the Company’s Current Report on

Form 8-K on June 20, 2019, and incorporated by reference herein).

Form of Indemnification Agreement for officers and directors (filed as Exhibit 10.9 to the Company’s Registration Statement on Form S-1 on August 14,

PDS Biotechnology 2010 Equity Incentive Plan, and forms of agreement thereunder (filed as Exhibit 10.2 to the Company’s Registration Statement on Form S-1/A on September 21, 2015, and incorporated by

reference herein).

Third Amended and Restated PDS Biotechnology Corporation 2014 Equity Incentive Plan (filed as Exhibit 10.1 to the Company’s Current Report on Form 8-K on July 17, 2023, and incorporated by reference

Employee Stock Option Agreement under the Third Amended and Restated PDS Biotechnology Corporation 2014 Equity Incentive Plan (filed as Exhibit 10.4 to the Company’s Current Report on Form 8-K filed on

December 9, 2020, and incorporated by reference herein).

PDS Biotechnology Corporation 2009 Stock Option Plan, as amended (filed as Exhibit 99.1 to the Company’s Registration Statement on Form S-8 on June 4, 2019, and incorporated by reference herein).

PDS Biotechnology Corporation 2018 Stock Option Plan (filed as Exhibit 99.2 to the Company’s Registration Statement on Form S-8 on June 4, 2019, and incorporated by reference herein).

Form of PDS Biotechnology Corporation Option Agreement for the PDS Biotechnology Corporation 2009 Stock Option Plan, as amended (filed as Exhibit 99.3 to the Company’s Registration Statement on Form S-8 on

June 4, 2019, and incorporated by reference herein).

Form of PDS Biotechnology Corporation Option Agreement for the PDS Biotechnology Corporation 2018 Stock Incentive Plan (filed as Exhibit 99.4 to the Company’s Registration Statement on Form S-8 on June 4,

2019, and incorporated by reference herein).

PDS Biotechnology Corporation 2019 Inducement Plan, as amended (filed as Exhibit 10.1 to the Company’s Current Report on Form 8-K filed on January 22, 2024, and incorporated by reference herein).

Form of Stock Option Grant Notice and Stock Option Agreement under the 2019 Inducement Plan (filed as Exhibit 10.2 to the Company’s Current Report on Form 8-K on June 20, 2019, and incorporated by reference

Form of Indemnification Agreement for officers and directors (filed as Exhibit 10.9 to the Company’s Registration Statement on Form S-1 on August 14, 2015, and incorporated by reference herein).

Sublease Agreement, effective as of March 5, 2020, by and between PDS Biotechnology Corporation and COWI North America, Inc.

(filed as Exhibit 10.37

to the Company’s Annual Report on Form 10-K filed on March 27, 2020, and incorporated by reference herein).

(filed as Exhibit 10.37 to the Company’s Annual Report on Form 10-K filed on

March 27, 2020, and incorporated by reference herein).

Patent License Agreement dated as of November 5, 2021, by and between PDS Biotechnology Corporation and the U.S.

Department of Health and Human

Services, as represented by the National Cancer Institute (filed as Exhibit 10.19 to the Company’s Annual Report on Form 10-K filed on March 31, 2022, and incorporated by reference herein).

Department of Health and Human Services, as represented by the National Cancer Institute

(filed as Exhibit 10.19 to the Company’s Annual Report on Form 10-K filed on March 31, 2022, and incorporated by reference herein).

Option Agreement with University of Georgia Research Foundation, Inc.

effective as of October 25, 2021 (filed as Exhibit 10.20 to the Company’s

Annual Report on Form 10-K filed on March 31, 2022, and incorporated by reference herein).

PDS Biotechnology Corporation Change of Control Severance Plan effective as of March 14, 2022 (filed as Exhibit 10.21 to the Company’s Annual Report

on Form 10-K filed on March 31, 2022, and incorporated by reference herein)

effective as of October 25, 2021 (filed as Exhibit 10.20 to the Company’s Annual Report on Form 10-K filed on March 31, 2022, and

incorporated by reference herein).

PDS Biotechnology Corporation Change of Control Severance Plan effective as of March 14, 2022 (filed as Exhibit 10.21 to the Company’s Annual Report on Form 10-K filed on March 31, 2022, and incorporated by

reference herein)

Amended and Restated Executive Employment Agreement by and between Frank K.

Bedu-Addo and PDS Biotechnology Corporation, effective as of March 14,

2022 (filed as Exhibit 10.22 to the Company’s Annual Report on Form 10-K filed on March 31, 2022, and incorporated by reference herein).

Bedu-Addo and PDS Biotechnology Corporation, effective as of March 14, 2022 (filed as Exhibit 10.22 to the Company’s Annual Report

on Form 10-K filed on March 31, 2022, and incorporated by reference herein).

Executive Employment Agreement by and between Gregory Conn, Ph.D.

and PDS Biotechnology Corporation, effective as of March 14, 2022 (filed as

Exhibit 10.23 to the Company’s Annual Report on Form 10-K filed on March 31, 2022, and incorporated by reference herein).

Executive Employment Agreement by and between Lars Boesgaard and PDS Biotechnology Corporation, effective as of November 28, 2023

and PDS Biotechnology Corporation, effective as of March 14, 2022 (filed as Exhibit 10.23 to the Company’s Annual Report on Form 10-K filed

on March 31, 2022, and incorporated by reference herein).

Executive Employment Agreement by and between Lars Boesgaard and PDS Biotechnology Corporation, effective as of November 28, 2023 (filed as Exhibit 10.26 to the Company’s Annual Report on Form 10-K filed on

March 28, 2024, and incorporated by reference herein).

Executive Employment Agreement by and between Kirk V.

Shephard, M.D.

and PDS Biotechnology Corporation, effective as of January 22, 2024.

Executive Employment Agreement by and between Spencer Brown and PDS Biotechnology Corporation, effective as of June 1, 2022 (filed as Exhibit 10.1

to the Company’s Quarterly Report on Form 10-Q filed on August 8, 2022, and incorporated herein by reference).

PDS Biotechnology Corporation Policy on Insider Trading

Subsidiary of PDS Biotechnology Corporation.

and PDS Biotechnology Corporation, effective as of January 22, 2024 (filed as Exhibit 10.27 to the Company’s Annual Report on Form 10-K

filed on March 28, 2024, and incorporated by reference herein).

Executive Employment Agreement by and between Spencer Brown and PDS Biotechnology Corporation, effective as of June 1, 2022 (filed as Exhibit 10.1 to the Company’s Quarterly Report on Form 10-Q filed on

August 8, 2022, and incorporated herein by reference).

Executive Employment Agreement by and between Stephan F.

Toutain and PDS Biotechnology Corporation, effective as of May 1, 2024 (filed as Exhibit 10.3 to the Company’s Quarterly Report on Form 10-Q filed on

May 15, 2024, and incorporated herein by reference).

Form of Securities Purchase Agreement, dated February 26, 2025, by and among PDS Biotechnology Corporation and the purchasers signatory thereto (filed as Exhibit 10.1 to the Company’s Current Report on Form

8-K filed on February 28, 2025, and incorporated by reference herein).

PDS Biotechnology Corporation Policy on Insider Trading (filed as Exhibit 19 to the Company’s Annual Report on Form 10-K filed on March 28, 2024, and incorporated by reference herein).

Subsidiary of PDS Biotechnology Corporation (filed as Exhibit 21.1 to the Company’s Annual Report on Form 10-K filed on March 28, 2024, and incorporated by reference herein).

Consent of KPMG LLP.

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Certification Pursuant to Section 906 of the Sarbanes-Oxley Act of 2002 (furnished herewith).

PDS Biotechnology Corporation Policy for Recovery of Erroneously Awarded Incentive Compensation.

Inline XBRL Instance Document (the instance document does not appear in the Interactive Data File because its XBRL tags are embedded within the

Inline XBRL document)

PDS Biotechnology Corporation Policy for Recovery of Erroneously Awarded Incentive Compensation (filed as Exhibit 97 to the Company’s Annual Report on Form 10-K filed on March 28, 2024, and incorporated by

reference herein).

Inline XBRL Instance Document (the instance document does not appear in the Interactive Data File because its XBRL tags are embedded within the Inline XBRL document)

Inline XBRL Taxonomy Extension Schema Document

XBRL Taxonomy Extension Calculation Linkbase Document

XBRL Taxonomy Extension Definition Linkbase Document

XBRL Taxonomy Extension Label Linkbase Document

XBRL Taxonomy Extension Presentation Linkbase Document

Cover Page Interactive Data File (formatted as inline XBRL and contained in Exhibit 101)

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Certain portions of this exhibit have been redacted pursuant to Item 601(b)(10)(iv) of Regulation S-K.

Pursuant to the requirements of Section 13 or 15(d) of the Securities Exchange Act of 1934, the Registrant has duly caused this Form 10-K to be signed on its behalf by the undersigned,

thereunto duly authorized.

Pursuant to the requirements of Section 13 or 15(d) of the Securities Exchange Act of 1934, the Registrant has duly caused this Form 10-K to be signed on its behalf by the undersigned, thereunto

duly authorized.

PDS Biotechnology Corporation

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Report of Independent Registered Public Accounting Firm

To the Stockholders and Board of

To the Stockholders and Board of Directors

PDS Biotechnology Corporation:

Opinion on the Consolidated Financial Statements

We have audited the accompanying consolidated balance sheets of PDS Biotechnology Corporation and subsidiary (the Company) as

of December 31, 2023 and 2022, the related consolidated statements of operations and comprehensive loss, changes in stockholders’ equity, and cash flows for the years then ended, and the related notes

(collectively, the consolidated financial statements).

In our opinion, the consolidated financial statements present fairly, in all material respects, the financial position of the Company as of December 31, 2023 and 2022, and the results

of its operations and its cash flows for each of the years then ended, in conformity with U.S.

We have audited the accompanying consolidated balance sheets of PDS Biotechnology Corporation and subsidiary (the

Company) as of December 31, 2024 and 2023, the related consolidated statements of operations and comprehensive loss, changes in stockholders’ equity, and cash flows for the years then ended, and

the related notes (collectively, the consolidated financial statements).

In our opinion, the consolidated financial statements present fairly, in all material respects, the financial position of the Company as of December 31, 2024 and

2023, and the results of its operations and its cash flows for each of the years then ended, in conformity with U.S.

generally accepted accounting principles.

Going Concern

The accompanying consolidated financial statements have been prepared assuming that the Company will continue as a going concern.

As discussed in

Note 3 to the consolidated financial statements, the Company has experienced net losses and negative cash flows from operations that raise substantial doubt about its ability to continue as a going

The accompanying consolidated financial statements have been prepared assuming that the Company will continue as a going

As discussed in Note 3 to the consolidated financial statements, the Company has experienced net losses and negative cash flows from operations that raise substantial doubt about its

ability to continue as a going concern.

Management’s plans in regard to these matters are also described in Note 3.

The consolidated financial statements do not include any adjustments that might result from the outcome of this uncertainty.

The consolidated financial statements do not include any adjustments that might result from the outcome of this

Basis for Opinion

These consolidated financial statements are the responsibility of the Company’s management.

Our responsibility is to express an opinion on these

consolidated financial statements based on our audit.

We are a public accounting firm registered with the Public Company Accounting Oversight Board (United States) (PCAOB) and are required to be independent with respect to the Company in

accordance with the U.S.

Our responsibility is to express an opinion on

these consolidated financial statements based on our audit.

We are a public accounting firm registered with the Public Company Accounting Oversight Board (United States) (PCAOB) and are required to be independent with respect to the

Company in accordance with the U.S.

federal securities laws and the applicable rules and regulations of the Securities and Exchange Commission and the PCAOB.

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reasonable assurance about whether the consolidated financial statements are free of material misstatement, whether due to error or fraud.

The Company is not required to have, nor were we engaged to perform, an audit of its internal control

over financial reporting.

As part of our audit, we are required to obtain an understanding of internal control over financial reporting but not for the purpose of expressing an opinion on the effectiveness of the Company’s internal control

over financial reporting.

The Company is not required to have, nor were we engaged to perform, an audit of its internal

control over financial reporting.

As part of our audit, we are required to obtain an understanding of internal control over financial reporting but not for the purpose of expressing an opinion on the effectiveness of the Company’s

internal control over financial reporting.

Accordingly, we express no such opinion.

Our audit included performing procedures to assess the risks of material misstatement of the consolidated financial statements, whether due to

error or fraud, and performing procedures that respond to those risks.

Our audit included performing procedures to assess the risks of material misstatement of the consolidated financial statements, whether due

to error or fraud, and performing procedures that respond to those risks.

Such procedures included examining, on a test basis, evidence regarding the amounts and disclosures in the consolidated financial statements.

Our audit also included

evaluating the accounting principles used and significant estimates made by management, as well as evaluating the overall presentation of the consolidated financial statements.

We believe that our audit provides a reasonable basis for our

Our audit also

included evaluating the accounting principles used and significant estimates made by management, as well as evaluating the overall presentation of the consolidated financial statements.

We believe that our audit provides a reasonable

basis for our opinion.

Critical Audit Matters

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(1) relate to accounts or disclosures that are material to the consolidated financial statements and (2) involved our especially challenging, subjective, or complex judgments.

determined that there are no critical audit matters.

We determined that there are no critical audit matters.

We have served as the Company’s auditor since 2019.

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Cash and cash equivalents

Prepaid expenses and other

Prepaid expenses and other assets

Total current assets

Property and equipment, net

Financing lease right-to-use assets

Operating lease right-to-use asset

Financing lease right-of-use assets

LIABILITIES AND STOCKHOLDERS’ EQUITY

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Financing lease obligation - short term

Operating lease obligation - short term

Total current liabilities

Noncurrent liabilities:

Notes payable, net of debt discount

Note payable, net of debt discount

Financing lease obligation-long term

Operating lease obligation-long term

Total liabilities

Commitments and contingencies (Note 11)

STOCKHOLDERS’ EQUITY

Common stock, $ 0.00033 par value, 75,000,000 shares authorized at December 31, 2023 and December 31, 2022, 33,094,521 shares and 30,170,317 shares

issued and outstanding at December 31, 2023 and December 31, 2022, respectively

Common stock, $ 0.00033 par value, 150,000,000 and 75,000,000

shares authorized at December 31, 2024 and December 31, 2023 , 37,987,380 shares and 33,094,521 shares issued and outstanding at December 31, 2024 and December 31, 2023 , respectively

Additional paid-in capital

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January 1, 2023

( 101,558,417

Stock-based compensation expense

Issuances of common stock, from exercise of stock options

Issuances of common stock from the Sales Agreement, net

Balance - March 31, 2023

( 111,218,335

Stock-based compensation expense

Issuances of common stock, from exercise of stock options

Issuance of common stock for consulting agreement

Issuances of common stock from the Sales Agreement, net

Balance - June 30, 2023

( 122,753,230

Stock-based compensation expense

Issuance of warrants

Issuances of common stock from the Sales Agreement, net

Balance - September 30, 2023

( 133,602,399

Stock-based compensation expense

Issuances of common stock, from exercise of stock options

Net shares for settlements of equity awards and taxes

Issuance of common stock for licensing agreement

Issuance of common stock for consulting agreement

Issuances of common stock from the Sales Agreement, net

Balance - December 31, 2022

December 31, 2023

( 144,500,615

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Issuances of common stock from the Sales Agreement, net

Issuances of common stock, from exercise of stock options

Balance - March 31, 2024

1 unchanged sentence

Stock-based compensation expense

Issuances of common stock, from exercise of stock options

Issuance of common stock for consulting agreement

Issuance of common stock from the Sales Agreement, net

Balance - June 30, 2024

1 unchanged sentence

Stock-based compensation expense

Issuance of common stock from the Sales Agreement, net

Ammortization of issuance costs related to the Sales Agreement

Issuances of common stock, from exercise of stock options

Balance - September 30, 2024

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Issuances of common stock, from exercise of stock options

Issuance of common stock for consulting agreement

Issuance of common stock from the Sales Agreement, net

Issuances of common stock from the Sales Agreement, net

Balance - December 31, 2024

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Stock-based compensation expense

Issuance of shares in licensing agreement

Issuance of shares in consulting agreement

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Changes in operating assets and liabilities:

Prepaid expenses and other assets

Finance lease right-to-use asset

Prepaid expenses and other current assets

Accounts payable

Accrued expenses

Finance lease liabilities

Operating lease liabilities

Net cash used in operating activities

Cash flows from investing activities:

Purchase of equipment

Net cash used in investing activities

Cash flows from financing activities:

Proceeds from issuance of note payable

Payment for debt issuance costs

Proceeds from exercise of stock options

Payments of finance lease obligations

Payment of taxes in equity transaction

Payment of loan principal

Proceeds from issuances of common stock, net of issuance costs

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Cash paid for interest

Fair value of warrants issued in connection with debt

See accompanying notes to the consolidated financial statements.

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When paired with an antigen, which is a disease-related protein that is recognizable by the immune system,

Versamune® and Infectimune® have both been shown to induce, in vivo, large quantities of high-quality, highly potent polyfunctional CD4

helper and CD8 killer T cells, a specific sub-type of T cell that is more effective at killing infected or target cells.

PDS01ADC is a novel investigational tumor-targeting fusion protein of Interleukin 12 that enhances the proliferation,

potency, infiltration and longevity of T cells in the tumor microenvironment and is therefore designed to overcome the limitations of cytokine therapy which today has resulted in high toxicity and limited therapeutic potential.

Versamune® and Infectimune® have both been shown to induce, in

vivo , large quantities of

high-quality, highly potent polyfunctional CD4 helper and CD8 killer T cells, a specific sub-type of T cell that is more effective at killing infected or target cells.

PDS01ADC is a novel investigational tumor-targeting fusion protein of

Interleukin 12 that enhances the proliferation, potency, infiltration and longevity of T cells in the tumor microenvironment and is therefore designed to overcome the limitations of cytokine therapy which today has resulted in high

toxicity and limited therapeutic potential.

Infectimune® is also designed to promote the induction of disease-specific neutralizing antibodies.

The Company’s immuno-oncology product candidates are of potential interest for use as a component of combination product candidates (for

example, in combination with other leading technologies such as immune checkpoint inhibitors) to provide more effective treatments across a range of advanced and/or refractory cancers.

The Company is also evaluating its immunotherapies as

monotherapies in early-stage disease.

The Company is developing targeted product candidates to treat several cancers, including Human Papillomavirus (HPV) associated cancers, melanoma, colorectal, lung, breast and prostate cancers.

Company’s infectious disease candidate is of potential interest for use in universal influenza vaccines.

The Company’s immuno-oncology product candidates are of potential interest for use as a

component of combination product candidates (for example, in combination with other therapies such as immune checkpoint inhibitors) to provide more effective treatments across a range of advanced and/or refractory cancers.

The Company is

also evaluating its immunotherapies as monotherapies in early-stage disease.

The Company is developing targeted product candidates to treat several cancers, including Human Papillomavirus (HPV) associated cancers, melanoma, colorectal,

lung, breast and prostate cancers.

The Company’s infectious disease candidate is of potential interest for use in universal influenza vaccines.

The Company has received numerous patents, submitted patent applications and owns substantial know-how and trade secrets

related to its Versamune® and PDS01ADC product platforms.

PDS Biotech holds thirteen ( 13 ) U.S.

granted claims directed to its platform technology and twenty-four ( 24 ) pending U.S.

As of March 1, 2025, the Company holds fourteen ( 14 ) U.S.

granted claims directed to its platform technology and twelve ( 12 ) pending U.S.

patent applications.

These issued patents will expire in 2026 to 2037.

Should the more recently submitted patent applications currently in prosecution be issued, these

will expire in 2033 through 2043 assuming no patent term extensions are granted.

As of March 1, 2024, PDS Biotech holds seventy-four

( 74 ) issued foreign patents and forty-four

Should the more recently submitted patent applications currently in prosecution be

issued, these will expire in 2033 through 2043 assuming no patent term extensions are granted.

As of March 1, 2025, the Company holds seventy-seven

( 77 ) issued foreign patents and twenty-eight

( 28 ) pending or published foreign patent applications.

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up-front cash payment of $ 5.0 million to Merck KGaA, Darmstadt, Germany, and (ii) entered into a Share Transfer Agreement dated

December 30, 2022 (the “Share Transfer Agreement”), pursuant to which the Company issued 378,787 shares of its common stock

(the “Shares”) to Merck KGaA, Darmstadt, Germany in a private placement for an aggregate value of $ 5.0 million, as measured by

the closing price of the Company’s common stock on the Nasdaq Capital Market as of December 30, 2022.

December 30, 2022 (the “Share Transfer Agreement”), pursuant to which the Company issued 378,787 shares of its common stock to

Merck KGaA, Darmstadt, Germany in a private placement for an aggregate value of $ 5.0 million, as measured by the closing price of

the Company’s common stock on the Nasdaq Capital Market as of December 30, 2022.

Pursuant to the License Agreement, the Company agreed to make certain

commercial sales milestone and royalty payments.

commercial sales milestones and royalty payments.

Note 2 – Summary of Significant Accounting Policies

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Cash equivalents and concentration of cash balance:

The Company considers all highly liquid securities with a maturity weighted average of less than three months to be cash

The Company’s cash and cash equivalents in bank deposit accounts, at times, may exceed federally insured limits.

The Company considers all highly liquid securities with a maturity of less than three months to be cash equivalents.

Company’s cash and cash equivalents in bank deposit accounts, at times, may exceed federally insured limits.

Property and equipment:

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Stock-based compensation:

The Company accounts for its stock-based compensation in accordance with ASC Topic 718, Compensation—Stock

Compensation (“ASC 718”).

ASC 718 requires all stock-based payments to employees, directors and non-employees to be recognized as expense in the consolidated statements of operations and comprehensive loss based on their grant date fair

The Company accounts for its stock-based compensation in accordance with ASC Topic 718, Compensation—Stock Compensation (“ASC 718”).

ASC 718 requires all stock-based payments to employees, directors and non-employees to be recognized as expense in the consolidated statements of operations and

comprehensive loss based on their grant date fair values.

In order to determine the fair value of stock options on the date of grant, the Company uses the Black-Scholes option-pricing model.

Inherent in this model are assumptions related to expected stock-price volatility, option

term, risk-free interest rate and dividend yield.

While the risk-free interest rate and dividend yield are less subjective assumptions that are based on factual data derived from public sources, the expected stock-price volatility and option

term assumptions require a greater level of judgment.

The Company expenses the fair value of its stock-based compensation awards to employees and directors on a straight-line basis over the requisite service period, which is generally the

vesting period.

Inherent in this model are assumptions

related to expected stock-price volatility, option term, risk-free interest rate and dividend yield.

While the risk-free interest rate and dividend yield are less subjective assumptions that are based on factual data derived from public

sources, the expected stock-price volatility and option term assumptions require a greater level of judgment.

The Company expenses the fair value of its stock-based compensation awards to employees and directors on a straight-line basis over

the requisite service period, which is generally the vesting period.

The Company recognizes forfeitures as they occur.

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Fair value of financial instruments:

ASC Topic 820, Fair Value Measurement Disclosures, specifies a hierarchy of valuation techniques based on whether the inputs

to those valuation techniques are observable or unobservable.

ASC Topic 820, Fair Value Measurement Disclosures , specifies a hierarchy of

valuation techniques based on whether the inputs to those valuation techniques are observable or unobservable.

Observable inputs reflect market data obtained from independent sources, while unobservable inputs reflect market assumptions.

The hierarchy gives the highest priority to

unadjusted quoted prices in active markets for identical assets or liabilities (Level 1 measurement) and the lowest priority to unobservable inputs (Level 3 measurement).

hierarchy gives the highest priority to unadjusted quoted prices in active markets for identical assets or liabilities (Level 1 measurement) and the lowest priority to unobservable inputs (Level 3 measurement).

The three levels of the fair value hierarchy are as follows:

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Recently Adopted Accounting Pronouncements

Recently issued accounting pronouncements did not, or are not believed by management to, have a material effect on

our present or future consolidated financial statements.

Recent Accounting Pronouncements Not Yet Adopted

In November 2023, the FASB issued ASU 2023-07, Segment Reporting (Topic 280):

Improvements to Reportable Segment Disclosures, which improves the disclosures required for reportable segments in the Company’s annual and interim

financial statements, primarily through enhanced disclosures about significant segment expenses.

ASU 2023-07 is effective for annual periods beginning after December 15, 2023 and interim periods within fiscal years beginning after

December 15, 2024.

Adoption of this ASU should be applied retrospectively to all prior periods presented in the financial statements.

Early adoption is permitted.

The Company is currently evaluating the impact that adopting this

standard will have on the consolidated financial statements and disclosures.

In December 2023, the FASB issued ASU 2023-09, Improvements to Income Tax Disclosures, which requires public entities, on an annual basis, to

provide disclosures of specific categories in the rate reconciliation, additional information for reconciling items that meet a quantitative threshold and income taxes paid disaggregated by jurisdiction.

ASU 2023-09 is effective

for annual periods beginning after December 15, 2024.

to Reportable Segment Disclosures , which improves the disclosures required for reportable segments in the Company’s annual and interim financial statements, primarily through enhanced disclosures about significant segment

ASU 2023-07 is effective for annual periods beginning after December 15, 2023 and interim periods within fiscal years beginning after December 15, 2024.

The Company adopted this ASU for the annual period ended December 31, 2024

and the amendments have been applied retrospectively to all prior periods presented in these consolidated financial statements by expanding the disclosure of expenses included in segment measures of profitability.

Refer to our segments

disclosure in Note 14 – Segment Reporting for more information.

Recent Accounting Pronouncements Not Yet Adopted

In December 2023, the FASB

issued ASU 2023-09, Improvements to Income Tax Disclosures , which requires public entities, on an annual basis, to provide disclosures of specific categories in the rate reconciliation,

additional information for reconciling items that meet a quantitative threshold and income taxes paid disaggregated by jurisdiction.

ASU 2023-09 is effective for annual periods beginning after December 15, 2024.

The Company has

evaluated the impact that adopting this standard and does not believe it will have a material impact on the consolidated financial statements and disclosures.

In November 2024, the FASB issued ASU No.

2024-03, Income Statement - Reporting Comprehensive Income - Expense Disaggregation

Disclosures (Subtopic 220-40):

Disaggregation of Income Statement Expenses.

The new guidance requires a public business entity to provide disaggregated disclosures, in the notes to the financial statements, of certain

categories of expenses that are included in expense line items on the face of the Statement of Operations and Comprehensive Loss.

The amendments in this Update are effective for annual reporting periods beginning after December

15, 2026, and interim reporting periods beginning after December 15, 2027.

Early adoption is permitted.

The Company is currently evaluating the impact that adopting this standard will have on the consolidated financial statements and disclosures.

The Company is currently evaluating the impact that the new guidance will have on the Company’s consolidated financial

Note 3 – Liquidity and Capital Resources

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call the outstanding balance of the term loans if the minimum cash balances outlined in the Loans and Security Agreement are not maintained.

The Company funds its operations through equity and/or debt financings such as the following:

In April 2022, the Company received approximately $ 1.2 million from the net sale of tax benefits to an unrelated, profitable New Jersey corporation pursuant the Company’s participation in the New Jersey Technology

Business Tax Certificate Transfer NOL program for tax year 2020.

The Company has funded its operations through the sale of NOL’s, equity and/or debt financings such as the following:

In August 2022, the Company filed a shelf registration statement, or the 2022 Shelf Registration Statement, with the SEC for

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The 2022 Shelf Registration Statement was declared effective on September 2, 2022.

August 2022, the Company entered into an At Market Issuance Sales Agreement, or the Sales Agreement, with B.

In August 2022, the Company entered into an At Market Issuance Sales Agreement, or the Sales Agreement, with B.

Riley Securities, Inc.

and BTIG, LLC, each an Agent and collectively the Agents, with respect to an at-the-market offering program

under which the Company may offer and sell, from time to time at its sole discretion, shares of its common stock, having an aggregate offering price of up to $ 50.0 million, or the Placement Shares, through or to the Agents, as sales agents or principals.

Upon delivery of a placement notice and subject to the terms and conditions of the Sales Agreement, the Agents

may sell the Placement Shares by any method permitted by law deemed to be an “at the market” offering as defined in Rule 415 of the Securities Act of 1933, as amended, including, without limitation, sales made through The Nasdaq Capital

Market or on any other existing trading market for the Company’s common stock.

The Agents will use commercially reasonable efforts to sell the Placement Shares from time to time, based upon the Company’s instructions (including any price,

time or size limits or other customary parameters or conditions the Company may impose).

The Company will pay the Agents a commission equal to three percent ( 3 %) of the gross sales proceeds of any Placement Shares sold through the Agents under the Sales Agreement, and the Company has also provided the Agents with customary indemnification and contribution

and BTIG, LLC, each an Agent and collectively the Agents, with respect to an

at-the-market offering program under which the Company may offer and sell, from time to time at its sole discretion, shares of its common stock, having an aggregate offering price of up to $ 50.0 million, or the Placement Shares, through or to the Agents, as sales agents or principals.

Upon delivery of a placement notice and subject to the terms and

conditions of the Sales Agreement, the Agents may sell the Placement Shares by any method permitted by law deemed to be an “at the market” offering as defined in Rule 415 of the Securities Act of 1933, as amended, including, without

limitation, sales made through The Nasdaq Capital Market or on any other existing trading market for the Company’s common stock.

The Agents will use commercially reasonable efforts to sell the Placement Shares from time to time, based upon

the Company’s instructions (including any price, time or size limits or other customary parameters or conditions the Company may impose).

Agents with customary indemnification and contribution rights.

The Company is not obligated to make any sales of its common stock under the Sales Agreement.

The offering of Placement Shares pursuant to the Sales Agreement will terminate upon the earlier of (i) the sale of all Placement Shares

subject to the Sales Agreement or (ii) termination of the Sales Agreement in accordance with its terms.

For the year ended December 31, 2023, the Company sold 2,642,269 shares of common stock for a net value of $ 16.1 million pursuant to the Sales

For the year ended December 31, 2022, the Company sold 1,238,491 shares of our common stock for a net value of $ 9.9 million pursuant to the Sales Agreement.

As of the date of this Annual Report, in the first quarter of 2024, the Company sold 3,428,681 shares of common stock for a net value of $ 19.5 million pursuant to the Sales Agreement.

The offering of Placement Shares pursuant to the Sales Agreement will terminate

upon the earlier of (i) the sale of all Placement Shares subject to the Sales Agreement or (ii) termination of the Sales Agreement in accordance with its terms.

In August 2024, the Company entered into an Amended and Restated At Market

Issuance Sales Agreement, or the New Sales Agreement, with B.

Riley Securities, Inc.

Wainwright & Co., LLC, with terms that are substantially consistent with those included in the original Sales Agreement.

The New Sales

Agreement superseded and replaced the Sales Agreement.

For the year ended December 31, 2024, the Company sold 3,428,681 shares

of common stock for a net value of $ 19.5 million pursuant to the Sales Agreement and 1,108,105 shares of common stock for a net value of $ 3.2

million pursuant to the New Sales Agreement.

For the year ended December 31, 2023, the Company sold 2,642,269 shares of our

common stock for a net value of $ 16.1 million pursuant to the Sales Agreement.

As of the date of this Annual Report, in the first

quarter of 2025, the Company sold 205,350 shares of common stock for a net value of $ 0.30 million pursuant to the New Sales Agreement.

In August 2022, the Company entered into a venture loan and security agreement, or the Loan and Security Agreement, with Horizon

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In total, the Company received $ 24.6 million in net

proceeds Loan E and Loan F were uncommitted Loans that could have been advanced by the lenders upon the parties agreement prior to July 31, 2023 upon the satisfaction of certain conditions.

Loan E and Loan F were uncommitted Loans that could have been advanced by the lenders upon the parties agreement prior to July 31, 2023 upon the satisfaction of certain conditions.

At this time the option to advance Loan E and Loan F

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Payments on the principal

balance begin on October 1, 2024 and are paid monthly in the succeeding 24 months.

balance began on October 1, 2024 and are paid monthly in the succeeding 24 months.

The principal balance of each Loan bears a

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Agreement, or any successor publication thereto, as the “ prime rate ” then in effect, plus (b) 5.75 %;

provided that, in the event

such rate of interest is less than 4.00 %, such rate shall be deemed to be 4.00 % for purposes of calculating the interest rate.

provided that, in the event such rate of interest is less than 4.00 %, such rate shall be deemed to be 4.00 % for purposes of

calculating the interest rate.

Interest is payable on a monthly basis based on each Loan principal amount outstanding the preceding month.

Company, at its option upon at least ten ( 10 ) business days’ written notice to the lenders, may prepay all (and not less than all) of

the outstanding Loan by simultaneously paying to each lender an amount equal to (i) any accrued and unpaid interest on the outstanding principal balance of the Loans;

plus (ii) an amount equal to (A) if such Loan is prepaid on or before the

Loan Amortization Date (as defined in the Loan and Security Agreement) applicable to such Loan, 3 % of the then outstanding principal

balance of such Loan, (B) if such Loan is prepaid after the Loan Amortization Date applicable to such Loan, but on or before the date that is 12 months after such Loan Amortization Date, 2 % of the then outstanding principal balance of such Loan, or (C) if

such Loan is prepaid more than 12 months after the Loan Amortization Date but prior to the stated maturity date applicable to such

Loan, 1 % of the then outstanding principal balance of such Loan;

The Company, at its option upon at least ten ( 10 ) business days’ written notice to the lenders, may prepay all (and not less than all) of the outstanding Loan by simultaneously paying to each lender an amount equal to

(i) any accrued and unpaid interest on the outstanding principal balance of the Loans;

plus (ii) an amount equal to (A) if such Loan is prepaid on or before the Loan Amortization Date (as defined in the Loan and Security Agreement) applicable

to such Loan, 3 % of the then outstanding principal balance of such Loan, (B) if such Loan is prepaid after the Loan Amortization

Date applicable to such Loan, but on or before the date that is 12 months after such Loan Amortization Date, 2 % of the then outstanding principal balance of such Loan, or (C) if such Loan is prepaid more than 12 months after the Loan Amortization Date but prior to the stated maturity date applicable to such Loan, 1 % of the then outstanding principal balance of such Loan;

plus (iii) the outstanding principal balance of such Loan;

(iv) all other sums, if any, that shall have become due and payable thereunder.

No prepayment premium will be applied to any

outstanding balance of any Loan paid on the stated maturity date.

The Loan and Security Agreement contains customary representations, warranties and covenants, including maintenance of

minimum cash balances as well as covenants by the Company limiting additional indebtedness, liens, including on intellectual property, guaranties, mergers and consolidations, substantial asset sales, investments and loans, certain corporate

changes, transactions with affiliates and fundamental changes.

In April 2023, the Company received approximately $ 1.4

million from the net sale of tax benefits to an unrelated, profitable New Jersey corporation pursuant to the Company’s participation in the New Jersey Technology Business Tax Certificate Transfer NOL program for tax year 2021.

plus (iv) all other sums, if any, that shall have

become due and payable thereunder.

No prepayment premium will be applied to any outstanding balance of any Loan paid on the stated

maturity date.

Loan and Security Agreement contains customary representations, warranties and covenants, including maintenance of minimum cash balances as well as covenants by the Company limiting additional indebtedness, liens, including on

intellectual property, guaranties, mergers and consolidations, substantial asset sales, investments and loans, certain corporate changes, transactions with affiliates and fundamental changes.

In April 2023, the Company received approximately $ 1.4 million from the net sale of tax benefits to an unrelated, profitable New Jersey corporation pursuant to the Company’s participation in the New Jersey Technology Business

Tax Certificate Transfer NOL program for tax year 2021.

In April 2024, the Company received approximately $ 0.9 million from the net sale of tax benefits to an unrelated,

profitable New Jersey corporation pursuant to the Company’s participation in the New Jersey Technology Business Tax Certificate Transfer NOL program for tax year 2022.

In February 2025, the Company entered into a Securities Purchase Agreement with certain purchasers, pursuant to which the Company agreed to sell an aggregate of 6,396,787 shares of common stock, pre-funded warrants to purchase up to an aggregate of 933,334 shares of common stock, and common stock warrants to purchase up to an aggregate of 7,330,121 shares of common stock at a combined purchase price of $ 1.50

per share and warrant (the “February 2025 Offering”).

Two of the Company’s directors participated in the February 2025

Offering and purchased 30,121 shares of common stock in the aggregate at an offering price per share of $ 1.66 and common stock warrants to purchase 30,121

shares of common stock.

The common stock warrants issued to the Company’s directors have an exercise price per share of $ 1.53 ,

but are otherwise identical to the common stock warrants issued to all other participants in the February 2025 Offering.

Aggregate gross proceeds from the February 2025 Offering were approximately $ 11 million.

Net proceeds to the Company from the offering, after deducting the placement agent fees and other estimated offering expenses

payable by the Company, were approximately $ 10.05 million.

The February 2025 Offering closed on February 28, 2025.

Going Concern

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allows for the lenders to call the outstanding balance of the term loans if the minimum cash balances outlined in the Loan and Security Agreement are not maintained.

The Company’s budgeted cash requirements in 2024 and beyond include expenses related to continuin g development and clinical trials as well as payments on our debt .

The Company’s budgeted cash requirements in 2025 and beyond include expenses related to continuin g development and clinical trials as well as payments on its debt .

The Company plans to execute its operating plan by obtaining additional capital,

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Cash and cash equivalents

The carrying value of the Loan and Security Agreement approximated its fair value at December 31, 2023 due to its variable rate.

The carrying value of the Loan and Security Agreement approximated its fair value at December 31, 2024 and December 31, 2023 due to its variable rate.

The fair value of the Company ’ s long-term debt is based on Level 2 inputs.

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Note 6 – Leases

Operating Lease

Effective March 5, 2020, the Company entered into a sublease for approximately 11,200 square feet of office space located at 25B Vreeland Road, Suite 300, Florham Park, NJ.

The sublease commenced on May 1, 2020 and will continue for a term of forty ( 40 ) months with an option to renew through October 31, 2027.

Operating and Financing Leases

Effective March 5, 2020, the Company entered into a sublease for approximately 11,200 square feet of office space located at 25B Vreeland Road, Suite 300, Florham Park, New Jersey.

The sublease commenced on May 1, 2020 with a term of forty ( 40 ) months and an option to renew through October 31, 2027.

sublease term expired on August 31, 2023, and was not renewed.

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The discount rate used to measure the operating lease liability as of May 1, 2020 was 9.15 %.

Throughout the period described above, the Company has maintained, and continues to maintain, a month-to-month lease for its research facilities at the Princeton Innovation Center BioLabs located at 303A College Road E, Princeton NJ, 08540.

College Road E, Princeton New Jersey.

Supplemental cash flow information related to operating leases is as follows:

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The aggregate monthly payments are approximately $ 6,000 .

During the year ended December 31, 2023, the Company exercised a bargain purchase option, which resulted in recognition of property and equipment of $ 151,490 .

During the year ended December 31, 2023, the Company exercised a bargain purchase option, which resulted in recognition of property

and equipment of $ 151,490 .

Finance lease amortization expense for the years ended December 31, 2024 and 2023 was $ 38,679 and $ 39,967 , respectively.

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General and administrative

The following table summarizes the stock option activity for the Company’ stock option plans for the year ended December 31, 2023:

The following table summarizes the stock option activity for the Company’s stock option plans for the year ended December 31, 2024:

Exercise Price

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As of December 31, 2024 there was approximately $ 10,633,050 of unamortized stock compensation expense, which is expected to be recognized over a remaining average vesting period of 2.54 years.

The Company entered into an agreement with DC Consulting for certain consulting services and issued 200,000 shares in connection with the agreement.

The weighted-average grant date fair value of the stock options granted in 2024 was $ 4.70 per share.

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that the Company has never paid cash dividends and has no present intention to pay cash dividends.

During the year ended December 31, 2023, the Company entered into a Common Stock Purchase Agreement, dated October 11,

2023, with DC Consulting LLC (“DC”) and a Common Stock Purchase Agreement, dated April 12, 2023, with DC, pursuant to which the Company issued DC an aggregate of 200,000 shares of common stock as partial compensation for consulting services provided by DC to the Company pursuant to the Consulting Agreement, dated October 11, 2023, with DC

and the Consulting Agreement, dated April 12, 2023, with DC.

During the year ended December 31, 2024, the Company entered into a Common Stock Purchase Agreement, dated June 17,

2024, with DC, pursuant to which the Company issued DC 100,000 shares of common stock as partial consideration for

consulting services provided by DC to the Company pursuant to the Consulting Agreement, dated June 17, 2024, with DC.

On February 25, 2025, the Company entered into a Common Stock Purchase Agreement, with DC, pursuant to which the Company

issued DC 100,000 shares of common stock as partial consideration for the consulting services provided by DC to the Company

pursuant to the Consulting Agreement, dated February 25, 2025, with DC.

Note 9 – Stockholders’ Equity

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The Company currently has 150,000,000

shares of common authorized.

shares of common shares authorized.

Each holder of a share of common stock is entitled to one vote for each share of common stock.

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Exclusive License Agreement

Pursuant to the Merck KGaA License Agreement, we agreed to make (i) development and first commercial sales milestone payments

totaling up to $ 11 million upon the achievement of certain milestones, including the dosing of the fifth patient in a Phase3 trial

of the clinical candidate and first commercial sale of the product for a first and second indication in a major market, and (ii) up to $ 105

million upon achieving certain aggregate sales levels of the product.

We also agreed to pay Merck KGaA, Darmstadt, Germany a royalty of 10 % on aggregate net sales of product as specified in the Merck KGaA License Agreement on a product-by-product and country-by-country basis until the later of:

Pursuant to the Merck KGaA License Agreement, the Company agreed to make (i) development and first commercial sales milestone

payments totaling up to $ 11 million upon the achievement of certain milestones, including the dosing of the fifth patient in a

Phase 3 clinical trial of the clinical candidate and first commercial sale of the product for a first and second indication in a major market, and (ii) up to $ 105 million upon achieving certain aggregate sales levels of the product.

The Company also agreed to pay Merck KGaA, Darmstadt, Germany a royalty of 10 % on aggregate net sales of product as specified in the Merck KGaA License Agreement on a product-by-product and country-by-country basis until the later of:

(i) ten years after the first commercial sale of a product in a given country;

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The royalty rate is subject to reduction in that event that a product is not covered by a valid patent claim, a biosimilar to the compound or the product comes on the market in a particular

country, or if we obtain a license to any intellectual property owned or controlled by a third-party which but for such license would be infringed by making, using or selling the compound.

country, or if the Company obtains a license to any intellectual property owned or controlled by a third-party which but for such license would be infringed by making, using or selling the compound.

Legal Proceedings

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working capital or general corporate purposes.

Each Loan matures on the 48-month anniversary following the applicable date on which a Loan is made to or on account of the Company under the Loan and Security Agreement (the “Maturity Date”) unless accelerated

pursuant to agreed upon events of default.

accelerated pursuant to agreed upon events of default.

All amounts outstanding under each Loan will be due and payable upon the earlier of the Maturity Date or the acceleration of the loans and commitments upon an event of default.

Payments on the principal

balance begin on October 1, 2024 and are paid monthly in the succeeding 24 months.

the principal balance began on October 1, 2024 and are paid monthly in the succeeding 24 months.

Interest Rate .

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contemplated by the Loan and Security Agreement, or any successor publication thereto, as the “ prime rate ” then in effect, plus (b) 5.75 %;

provided that, in the event such rate of interest is less than 4.00 %, such rate shall be deemed to be 4.00 % for purposes of calculating the interest rate.

Interest is payable on a monthly basis based on each Loan principal amount outstanding the

preceding month.

provided that, in the event such rate of interest is less than 4.00 %, such rate shall be deemed to be 4.00 % for purposes of

calculating the interest rate.

Interest is payable on a monthly basis based on each Loan principal amount outstanding the preceding month.

Amortization.

Loan shall commence amortization upon the date set forth on the promissory note executed in connection with the respective Loan, upon which the Company is required to commence making equal payments of principal plus accrued interest on the

outstanding principal amount of the respect Loan (the “Loan Amortization Date”) and continuing thereafter on the first business day of each calendar month through the Maturity Date.

outstanding principal amount of the respective Loan (the “Loan Amortization Date”) and continuing thereafter on the first business day of each calendar month through the Maturity Date.

Prepayment Premium.

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plus (ii) an amount equal to (A) if such Loan is prepaid on or before the

Loan Amortization Date applicable to such Loan, three percent ( 3 %) of the then outstanding principal balance of such Loan, (B) if such Loan is prepaid after the Loan Amortization Date applicable to such Loan, but on or before the date that is twelve

( 12 ) months after such Loan Amortization Date, two percent ( 2 %) of the then outstanding principal balance of such Loan, or

(C) if such Loan is prepaid more than twelve ( 12 ) months after the Loan Amortization Date but prior to the stated Maturity Date

applicable to such Loan, one percent ( 1 %)

of the then outstanding principal balance of such Loan;

that is twelve ( 12 ) months after such Loan Amortization Date, two percent ( 2 %) of the then outstanding principal balance of

such Loan, or (C) if such Loan is prepaid more than twelve ( 12 ) months after the Loan Amortization Date but prior to the stated

Maturity Date applicable to such Loan, one percent ( 1 %) of the then outstanding principal balance of such Loan;

plus (iii) the outstanding principal balance of such Loan;

plus (iv) all other sums, if any, that shall

have become due and payable hereunder.

No prepayment premium will be applied to any outstanding balance of any Loan paid on the

stated Maturity Date.

all other sums, if any, that shall have become due and payable hereunder.

No prepayment premium will be applied to any outstanding

balance of any Loan paid on the stated Maturity Date.

Company’s obligations are secured by a security interest in all of the assets of the Company, subject to limited exceptions and excluding the Company’s intellectual property.

4 unchanged sentences

As of December 31,

2023, the Company is in compliance with all covenants.

2024, the Company is in compliance with all covenants in all material respects.

Default Provisions .

2 unchanged sentences

In connection with the Loan and Security Agreement, the Company issued Horizon Technology Finance Corporation and Powerscourt Investments XXV, LP warrants to purchase an aggregate total of 381,625 shares of the Company’s common stock at an initial exercise price of $ 3.6685

Each warrant is classified as equity and is exercisable at any time for a period beginning on the date of grant and ending on the earlier of (A) 10 years from the date of grant, and (B) the closing of (A) (i) the sale, lease, exchange, conveyance or other disposition of all or substantially all of the Company’s property or

business, or (ii) its merger into or consolidation with any other corporation (other than a wholly-owned subsidiary of the Company), or any transaction (including a merger or other reorganization) or series of related transactions, in which

more than 50 % of the voting power of the Company is disposed of, in each case, for cash or for marketable securities meeting certain

requirements as described in the applicable warrants.

The key assumptions used in Black-Scholes option pricing model were (i) expected term of 10 years , (ii) a risk-free rate of 3.11 %, (iii) expected volatility of 93.8 %, (iv) and no estimated dividend yield.

into or consolidation with any other corporation (other than a wholly-owned subsidiary of the Company), or any transaction (including a merger or other reorganization) or series of related transactions, in which more than 50 % of the voting power of the Company is disposed of, in each case, for cash or for marketable securities meeting certain requirements as described

in the applicable warrants.

The key assumptions used in Black-Scholes option pricing model were (i) expected term of 10 years , (ii)

a risk-free rate of 3.11 %, (iii) expected volatility of 93.8 %, (iv) and no estimated dividend yield.

the Company incurred third-party and lender fees of $ 449,329 .

9 unchanged sentences

employees subject to IRS-imposed limitations.

The 401(k) employer cash contribution match for the years ended December 31, 2023 and December 31, 2022 $ 181,439 and $ 157,009 , respectively.

The Company’s 401(k) employer cash contribution match for the years ended December 31, 2024 and December 31, 2023 $ 178,817 and $ 181,439 , respectively.

Note 14 – Segment

In accordance with FASB ASC Topic 280, Segment Reporting , the Company has determined that it operates as a single

reportable segment, developing a growing pipeline of targeted immunotherapies designed to overcome the limitations of current immunotherapy.

The financial results of the Company’s operations are managed and reported to the Chief Executive

Officer who is considered the Company’s chief operating decision maker (CODM), on a consolidated basis.

CODM assesses performance and allocates resources based on the Company’s consolidated statements of operations and key components and processes of the Company’s operations are managed centrally.

Segment asset information is not used by the CODM

to allocate resources.

As a single reportable segment entity, the

Company’s segment performance measure is net income / (loss) attributable to shareholders.

Significant segment expenses, as provided to the CODM, are presented below:

Year Ended December 31,

Segment expenses

Salaries and benefits

Professional fees

General administrative expenses

Clinical development expenses

Other development expenses

Total operating and segment expenses

Interest income

Interest expense

Benefit from income taxes

Segment and consolidated net loss

Note 15 – Subsequent Events

On January 22, 2024, the Company amended the Inducement Plan solely to increase the total number of shares of common stock reserved for issuance under the Inducement

Plan from 1,100,000 shares to 2,100,000

As of the date of this Annual Report,in the first quarter of 2024, the Company sold 3,428,681 shares of common stock for net proceeds of $ 19.5 million pursuant to its Sales Agreement .

As of the date of this Annual Report, during the first quarter of 2025, the Company sold 205,350 shares of common stock for net proceeds of $ 0.30

million pursuant to the New Sales Agreement .

In February 2025, the Company entered into a Securities Purchase

Agreement with certain purchasers, pursuant to which the Company agreed to sell an aggregate of 6,396,787 shares of common

stock, pre-funded warrants to purchase up to an aggregate of 933,334 shares of common stock, and common stock warrants to

purchase up to an aggregate of 7,330,121 shares of common stock at a combined purchase price of $ 1.50 per share and warrant (the “February 2025 Offering”).

Two of the Company’s directors participated in the February 2025 Offering and purchased 30,121 shares of common stock in the aggregate at an offering price per share of $ 1.66

and common stock warrants to purchase 30,121 shares of common stock.

The common stock warrants issued to the Company’s

directors have an exercise price per share of $ 1.53 , but are otherwise identical to the common stock warrants issued to all

other participants in the February 2025 Offering.

Aggregate gross proceeds from the February 2025 Offering were approximately $ 11

Net proceeds to the Company from the offering, after deducting the placement agent fees and other estimated offering expenses payable by the Company, were approximately $ 10.05 million.

The February 2025 Offering closed on February 28, 2025.

Compared sentence by sentence after normalising whitespace, quotation marks, case and digits, so re-formatting and restated figures do not read as changed language. Wording changes appear as one removal and one addition. The current filing and the prior one are authoritative.

What changed 10-K

Item 9A. Controls and Procedures